[Federal Register Volume 70, Number 1 (Monday, January 3, 2005)]
[Notices]
[Pages 120-123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28746]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA  259E]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 2005

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 2005.

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SUMMARY: This notice establishes initial 2005 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA).

DATES: Effective Date: January 3, 2005.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug & Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826) 
requires that the Attorney General establish aggregate production 
quotas for each basic class of controlled substance listed in Schedules 
I and II. This responsibility has been delegated to the Administrator 
of the DEA by Section 0.100 of Title 28 of the Code of Federal 
Regulations. The Administrator, in turn, has redelegated this function 
to the Deputy Administrator, pursuant to Section 0.104 of Title 28 of 
the Code of Federal Regulations.
    The 2005 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 2005 
to provide adequate supplies of each substance for: the estimated 
medical, scientific, research and industrial needs of the United 
States; lawful export requirements; and the establishment and 
maintenance of reserve stocks (21 U.S.C. 826(a) and 21 CFR 1303.11). 
These quotas do not include imports of controlled substances for use in 
industrial processes.
    On December 3, 2004, a notice of the proposed initial 2005 
aggregate production quotas for certain controlled substances in 
Schedules I and II was published in the Federal Register (69 FR 70284). 
All interested persons were invited to comment on or object to these 
proposed aggregate production quotas on or before December 27, 2004.
    Nine responses were received resulting in comments on a total of 
fourteen Schedules I and II controlled substances within the published 
comment period. The responses commented that the proposed aggregate 
production quotas for alfentanil, amphetamine, codeine, fentanyl, 
gamma-hydroxybutyric acid (GHB), hydromorphone, levorphanol, methadone, 
methadone intermediate, methamphetamine (for conversion), 
methylphenidate, oxymorphone and tetrahydrocannabinols were 
insufficient to provide for the estimated medical, scientific, research 
and industrial needs of the United States, for export requirements and 
for the establishment and maintenance of reserve stocks. One comment 
stated that the proposed aggregate production quota for 2,5-
dimethoxyamphetamine was too high.
    DEA has taken into consideration the above comments along with the 
relevant 2004 manufacturing quotas, current 2004 sales and inventories, 
2005 export requirements, and research and product development 
requirements. Based on this information, the DEA has adjusted the 
initial aggregate production quotas for hydromorphone, lysergic acid 
diethylamide, marihuana, methamphetamine (for conversion), and 
tetrahydrocannabinols to meet the legitimate needs of the United 
States.
    Regarding 2,5-dimehthoxyamphetamine, alfentanil, amphetamine, 
codeine, fentanyl, gamma-hydroxybutyric acid (GHB), levorphanol, 
methadone, methadone intermediate, methylphenidate and oxymorphone, the 
DEA has determined that the proposed initial 2005 aggregate production 
quotas are sufficient to meet

[[Page 121]]

the current 2005 estimated medical, scientific, research and industrial 
needs of the United States.
    Pursuant to Part 1303 of Title 21 of the Code of Federal 
Regulations, the Deputy Administrator of the DEA will, in 2005, adjust 
aggregate production quotas and individual manufacturing quotas 
allocated for the year based upon 2004 year-end inventory and actual 
2004 disposition data supplied by quota recipients for each basic class 
of Schedule I or II controlled substance.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the Controlled Substances Act of 1970 (21 U.S.C. 826), 
and delegated to the Administrator of the DEA by Section 0.100 of Title 
28 of the Code of Federal Regulations, and redelegated to the Deputy 
Administrator pursuant to Section 0.104 of Title 28 of the Code of 
Federal Regulations, the Deputy Administrator hereby orders that the 
2005 initial aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                          Established
                                                          initial 2005
                                                           quotas (g)
------------------------------------------------------------------------
Basic Class--Schedule I:
    2,5-Dimethoxyamphetamine.........................          2,801,000
    2,5-Dimethoxy-4-ethylamphetamine (DOET)..........                  2
    2,5-Dimethoxy-4-(n)-propylthiophenethylamine.....                 10
    3-Methylfentanyl.................................                  2
    3-Methylthiofentanyl.............................                  2
    3,4-Methylenedioxyamphetamine (MDA)..............                 15
    3,4-Methylenedioxy-N-ethylamphetamine (MDEA).....                  5
    3,4-Methylenedioxymethamphetamine (MDMA).........                 15
    3,4,5-Trimethoxyamphetamine......................                  2
    4-Bromo-2,5-dimethoxyamphetamine (DOB)...........                  2
    4-Bromo-2,5-dimethoxyphenethylamine (2-CB).......                  2
    4-Methoxyamphetamine.............................                  2
    4-Methylaminorex.................................                  2
    4-Methyl-2,5-dimethoxyamphetamine (DOM)..........                  2
    5-Methoxy-3,4-methylenedioxyamphetamine..........                  2
    5-Methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT).                 10
    Acetyl-alpha-methylfentanyl......................                  2
    Acetyldihydrocodeine.............................                  2
    Acetylmethadol...................................                  2
    Allylprodine.....................................                  2
    Alphacetylmethadol...............................                  2
    Alpha-ethyltryptamine............................                  2
    Alphameprodine...................................                  2
    Alphamethadol....................................                  3
    Alpha-methyltryptamine (AMT).....................                 10
    Alpha-methylfentanyl.............................                  2
    Alpha-methylthiofentanyl.........................                  2
    Aminorex.........................................                  2
    Benzylmorphine...................................                  2
    Betacetylmethadol................................                  2
    Beta-hydroxy-3-methylfentanyl....................                  2
    Beta-hydroxyfentanyl.............................                  2
    Betameprodine....................................                  2
    Betamethadol.....................................                  2
    Betaprodine......................................                  2
    Bufotenine.......................................                  2
    Cathinone........................................                  2
    Codeine-N-oxide..................................                252
    Diethyltryptamine................................                  2
    Difenoxin........................................              5,000
    Dihydromorphine..................................          1,551,000
    Dimethyltryptamine...............................                  3
    Gamma-hydroxybutyric acid........................          8,000,000
    Heroin...........................................                  2
    Hydromorphinol...................................                  2
    Hydroxypethidine.................................                  2
    Lysergic acid diethylamide (LSD).................                 61
    Marihuana........................................            913,020
    Mescaline........................................                  2
    Methaqualone.....................................                  5
    Methcathinone....................................                  4
    Methyldihydromorphine............................                  2
    Morphine-N-oxide.................................                252
    N,N-Dimethylamphetamine..........................                  2
    N-Ethylamphetamine...............................                  2
    N-Hydroxy-3,4-methylenedioxyamphetamine..........                  2
    Noracymethadol...................................                  2
    Norlevorphanol...................................                 52
    Normethadone.....................................                  2
    Normorphine......................................                 12

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    Para-fluorofentanyl..............................                  2
    Phenomorphan.....................................                  2
    Pholcodine.......................................                  2
    Propiram.........................................             50,000
    Psilocybin.......................................                  2
    Psilocyn.........................................                  7
    Tetrahydrocannabinols............................            312,500
    Thiofentanyl.....................................                  2
    Trimeperidine....................................                  2
Basic Class--Schedule II:
    1-Phenylcyclohexylamine..........................                  2
    Alfentanil.......................................              2,500
    Alphaprodine.....................................                  2
    Amobarbital......................................                  2
    Amphetamine......................................         12,700,000
    Cocaine..........................................            228,000
    Codeine (for sale)...............................         39,605,000
    Codeine (for conversion).........................         55,000,000
    Dextropropoxyphene...............................        167,365,000
    Dihydrocodeine...................................            748,000
    Diphenoxylate....................................            571,000
    Ecgonine.........................................             53,000
    Ethylmorphine....................................                  2
    Fentanyl.........................................          1,428,000
    Glutethimide.....................................                  2
    Hydrocodone (for sale)...........................         37,604,000
    Hydrocodone (for conversion).....................          1,500,000
    Hydromorphone....................................          2,751,000
    Isomethadone.....................................                  2
    Levo-alphacetylmethadol..........................                  2
    (LAAM) Levomethorphan............................                  2
    Levorphanol......................................              5,000
    Meperidine.......................................          9,753,000
    Metazocine.......................................                  1
    Methadone (for sale).............................         13,900,000
    Methadone Intermediate...........................         18,000,000
    Methamphetamine..................................          2,932,000
 
 [680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
  prescription product; 2,200,000 grams for methamphetamine mostly for
       conversion to a Schedule III product; and 52,000 grams for
                       methamphetamine (for sale)]
 
    Methylphenidate..................................         30,817,000
    Morphine (for sale)..............................         35,000,000
    Morphine (for conversion)........................        110,774,000
    Nabilone.........................................                  2
    Noroxymorphone (for sale)........................              1,002
    Noroxymorphone (for conversion)..................          4,000,000
    Opium............................................          1,180,000
    Oxycodone (for sale).............................         49,200,000
    Oxycodone (for conversion).......................            920,000
    Oxymorphone......................................            534,000
    Pentobarbital....................................         18,251,000
    Phencyclidine....................................              2,006
    Phenmetrazine....................................                  2
    Racemethorphan...................................                  2
    Secobarbital.....................................                  2
    Sufentanil.......................................              4,000
    Thebaine.........................................         72,453,000
------------------------------------------------------------------------

    The Deputy Administrator further orders that aggregate production 
quotas for all other Schedules I and II controlled substances included 
in Sections 1308.11 and 1308.12 of Title 21 of the Code of Federal 
Regulations be established at zero.
    The Office of Management and Budget has determined that notices of 
aggregate production quotas are not subject to centralized review under 
Executive Order 12866.
    This action does not preempt or modify any provision of state law; 
nor does it impose enforcement responsibilities on any state; nor does 
it diminish the power of any state to enforce its own laws. 
Accordingly, this action does not have federalism implications 
warranting the application of Executive Order 13132.
    The Deputy Administrator hereby certifies that this action will 
have no significant impact upon small entities whose interests must be 
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. 
The establishment of aggregate production quotas for Schedules I and II 
controlled substances is mandated by law and by international treaty 
obligations. The quotas are necessary to provide for the estimated 
medical, scientific, research and industrial needs of the United 
States, for export requirements and the establishment and maintenance 
of

[[Page 123]]

reserve stocks. While aggregate production quotas are of primary 
importance to large manufacturers, their impact upon small entities is 
neither negative nor beneficial. Accordingly, the Deputy Administrator 
has determined that this action does not require a regulatory 
flexibility analysis.
    This action meets the applicable standards set forth in Sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
    This action will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$114,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.
    This action is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This action 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

    Dated: December 29, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-28746 Filed 12-29-04; 10:58 am]
BILLING CODE 4410-09-P